Doctors Call For More Supplement Regulation

Dietary supplements accounted for more than half the Class 1 drugs recalled by the U.S. Food and Drug Administration from 2004-12, meaning they contained substances that could cause serious health problems or even death, a new study from St. Michael's Hospital has found.

The majority of those recalled supplements were bodybuilding, weight loss or sexual enhancement products that contain unapproved medicinal ingredients, including steroids, said the study's lead author, Dr. Ziv Harel.

Almost one-quarter of the substances are manufactured outside of the United States, he said in the study published online in the journal JAMA Internal Medicine.
Unlike pharmaceutical products, dietary supplements do not require FDA approval before they can be sold. The FDA defines a dietary supplement as a product taken by mouth that contains a "dietary ingredient" such as vitamins, minerals, herbs, other botanicals, amino acids or substances such as metabolites. There are about 65,000 dietary supplements on the market consumed by more than 150 million Americans.
Of the 465 drugs subject to a Class 1 recall in the U.S. between Jan. 1, 2004, and Dec. 19, 2012, 237 or 51 per cent were dietary supplements. The majority of recalls occurred after 2008 for reasons unknown, the researchers said.

Supplements marketed as sexual enhancement products were the most commonly recalled dietary supplements (95, or 40 per cent).

Dr. Harel, a nephrologist whose research focus is patient safety, said that when the FDA learns of an adulterated dietary supplement, it is required to contact the manufacturer to trace the source of the product and initiate a recall. However, a recent investigation by the Office of the Inspector general determined that the FDA does not possess accurate contact information for 20 per cent of supplement manufacturers.

The FDA has recently introduced a number of initiatives aimed at mitigating the impact of the most common adulterated supplements, including the creation of multinational enforcement groups and widespread media campaigns focusing on improving awareness. "Despite these initiatives, products subject to Class I recalls continue to be readily available for sale, which may be due to an increasingly complex distribution network associated with these products, as well as ineffective communication by the FDA to consumers," Dr. Harel said.

"We also found a number of recalled products to be manufactured outside of the U.S. where manufacturing practices may not be subject to the same oversight and regulation required of domestic companies."

Dr. Harel said increased efforts are needed to regulate this industry. "Keeping the status quo may taint the dietary supplement industry as a whole."

Story Source:
The above story is reprinted from materials provided by St. Michael's Hospital. The original article was written by Leslie Shepherd.
Note: Materials may be edited for content and length. For further information, please contact the source cited above.

Dietary supplements accounted for more than half the Class 1 drugs recalled by the U.S. Food and Drug Administration from 2004-12, meaning they contained substances that could cause serious health problems or even death, a new study from St. Michael's Hospital has found.

The majority of those recalled supplements were bodybuilding, weight loss or sexual enhancement products that contain unapproved medicinal ingredients, including steroids, said the study's lead author, Dr. Ziv Harel.

Almost one-quarter of the substances are manufactured outside of the United States, he said in the study published online in the journal JAMA Internal Medicine.
Unlike pharmaceutical products, dietary supplements do not require FDA approval before they can be sold. The FDA defines a dietary supplement as a product taken by mouth that contains a "dietary ingredient" such as vitamins, minerals, herbs, other botanicals, amino acids or substances such as metabolites. There are about 65,000 dietary supplements on the market consumed by more than 150 million Americans.
Of the 465 drugs subject to a Class 1 recall in the U.S. between Jan. 1, 2004, and Dec. 19, 2012, 237 or 51 per cent were dietary supplements. The majority of recalls occurred after 2008 for reasons unknown, the researchers said.

Supplements marketed as sexual enhancement products were the most commonly recalled dietary supplements (95, or 40 per cent).

Dr. Harel, a nephrologist whose research focus is patient safety, said that when the FDA learns of an adulterated dietary supplement, it is required to contact the manufacturer to trace the source of the product and initiate a recall. However, a recent investigation by the Office of the Inspector general determined that the FDA does not possess accurate contact information for 20 per cent of supplement manufacturers.

The FDA has recently introduced a number of initiatives aimed at mitigating the impact of the most common adulterated supplements, including the creation of multinational enforcement groups and widespread media campaigns focusing on improving awareness. "Despite these initiatives, products subject to Class I recalls continue to be readily available for sale, which may be due to an increasingly complex distribution network associated with these products, as well as ineffective communication by the FDA to consumers," Dr. Harel said.

"We also found a number of recalled products to be manufactured outside of the U.S. where manufacturing practices may not be subject to the same oversight and regulation required of domestic companies."

Dr. Harel said increased efforts are needed to regulate this industry. "Keeping the status quo may taint the dietary supplement industry as a whole."

Story Source:
The above story is reprinted from materials provided by St. Michael's Hospital. The original article was written by Leslie Shepherd.
Note: Materials may be edited for content and length. For further information, please contact the source cited above.

People don't understand how easy it is to get unsafe drugs passed by the FDA. Big Pharma is basically as bad as an un-policed supplement industry. They don't want supplements out there because people who use them RESPONSIBLY are much healthier than the average American who goes to there "trusted" doctor. Big Pharma alterate studies all the time in their favor. Just in the last few years Eli Lily got in trouble for it and they are one of the big manufacturers. Unless it is a severe case that really warrants the FDA keeping their own *sses out of hot water, it will pass.

This article is hilarious, it's a perfect example of media sensationalism. In the first paragraph it states how supplements make up " more then half" of the total class one drugs recalled in the US. Making it seem like dietary supplement make up a large majority of the recalled products. But then in paragraph 3 it gives the actual figures dietary supplements only make up 51 percent of recalls!!! Which means the FDA only has a one percent higher success rate then the private industry at regulating product.

All this article really shows is how ineffective the FDA is, and that privatized regulation of the dietary supplement industry is just as effective.

Useing scare tactics like saying a lot of supplements come from out of the country is idiotic. Of course a lot of the supplements are going to come from out of the US. A lot of the herbal supplements out there are native to foreign countries, so they have to grown there then shipped here.

This bull crap needs to stop, they do this all the time they use the media to stir up a frenzy among the uneducated and unhealthy. The people who don't even take the supps!!! Then the government bans the products for the 5-10 percent of us who actually do use them. Why don't they focus on getting rid of pop, and refined sugars and carbs rather then focusing on the small percentage of actually healthy people out there.

This article is hilarious, it's a perfect example of media sensationalism. In the first paragraph it states how supplements make up " more then half" of the total class one drugs recalled in the US. Making it seem like dietary supplement make up a large majority of the recalled products. But then in paragraph 3 it gives the actual figures dietary supplements only make up 51 percent of recalls!!! Which means the FDA only has a one percent higher success rate then the private industry at regulating product.

All this article really shows is how ineffective the FDA is, and that privatized regulation of the dietary supplement industry is just as effective.

Useing scare tactics like saying a lot of supplements come from out of the country is idiotic. Of course a lot of the supplements are going to come from out of the US. A lot of the herbal supplements out there are native to foreign countries, so they have to grown there then shipped here.

This bull crap needs to stop, they do this all the time they use the media to stir up a frenzy among the uneducated and unhealthy. The people who don't even take the supps!!! Then the government bans the products for the 5-10 percent of us who actually do use them. Why don't they focus on getting rid of pop, and refined sugars and carbs rather then focusing on the small percentage of actually healthy people out there.

It will not be banned because of Big Food lobbyists. The only way pop and other rather unhealthy things like refined sugars and carbs will get taken off the market is if people stop buying them. And looking at the condition of 'Murica right now, that's not happening. It's even more saddening that we would need the govt to save people from themselves. "I wish the govt would ban pop, I can't stop my fat self from drinking it." It's small things like that that slowly make its way into becoming a socialist society.

I don't think that Bigcountry was insinuating a socialist society by "banning pop". I think it is more frustration coming through in that the country doesn't focus on truly bad things for you like processed sugar, etc but rather minute things that they have the power to pick on and pretend to be proactive. One way or another there is a great degree of control, it's just subtle rather than out in the open like in a socialist environment.

I don't think that Bigcountry was insinuating a socialist society by "banning pop". I think it is more frustration coming through in that the country doesn't focus on truly bad things for you like processed sugar, etc but rather minute things that they have the power to pick on and pretend to be proactive. One way or another there is a great degree of control, it's just subtle rather than out in the open like in a socialist environment.

I don't think that Bigcountry was insinuating a socialist society by "banning pop". I think it is more frustration coming through in that the country doesn't focus on truly bad things for you like processed sugar, etc but rather minute things that they have the power to pick on and pretend to be proactive. One way or another there is a great degree of control, it's just subtle rather than out in the open like in a socialist environment.

I get where he was going with it. It comes more from how I feel about where we are heading versus anything bigcountry said. Politics is almost exactly that. Make it look like you are doing something while in the mean time a lot of times you are doing nothing good for anyone but yourself or what can forward your agenda. They piss and moan about gun control and can't even adequately enforce the laws in place that wouldn't need anymore gun control legislation. Case in point is this article. They are worried about DMAA. DMAA. In the grand scheme of things totally unimportant. It only really harms people who don't follow directions (which again why the govt thinks it needs to save people from themselves), had prior medical issues that were exasperated by DMAA, or were just plain overweight and looking for that magic pill. There is a cure for cancer out there, I firmly believe that. I also firmly believe that Big Pharma will never let it see the light of day due to the fact that cancer is a millions on top of millions of dollar industry. A few years ago they polled doctors and 90% said they would not undergo the treatment they recommend for their patients. If your cancer is caught early enough, they have a cancer treatment in Mexico that can put in remission without painful chemo and drugs. I know this was a little off-topic, but it explains my post more.

Everyone on this comment wall is acting like they took your protein Supps. Get over it. Yes, I agree most of the bull**** about Supps has to do with the government and doctors not getting money from it. However, talking about the article as if saying "more than half" vs. 51% is a scandal makes you sound ignorant. Then, you talk about banning pop? What the hell is the matter with you people. Pop is not good in large quantities, I agree. I don't drink it because I drink water before anything. However, eating too much lean chicken heightens cholesterol. Yet, we all do it. If you're going to post on here make intelligent arguments and quit adding to the "dumb-ass" meat head stereotype. Be a meat head, but be smart.

Everyone on this comment wall is acting like they took your protein Supps. Get over it. Yes, I agree most of the bull**** about Supps has to do with the government and doctors not getting money from it. However, talking about the article as if saying "more than half" vs. 51% is a scandal makes you sound ignorant. Then, you talk about banning pop? What the hell is the matter with you people. Pop is not good in large quantities, I agree. I don't drink it because I drink water before anything. However, eating too much lean chicken heightens cholesterol. Yet, we all do it. If you're going to post on here make intelligent arguments and quit adding to the "dumb-ass" meat head stereotype. Be a meat head, but be smart.

Hey hey. I never said to ban pop. I said people need to be responsible for themselves. All it takes is the govt to get a hook in somewhere and they can pretty much do what they want. You are correct, they probably won't take away protein powder. There are still people in the GENERAL PUBLIC that believe creatine is a steroid. That is who politicians go after when they have an agenda. The general public. It wouldn't do them any good to go against the general LIFTING public because most of us know, even if some are still stupid, that you shouldn't overdo certain supplements, that you should get educated about certain supplements. There was an article in SI about 6 years ago where multiple men were in a jaundiced state due to superdrol and its clones. These dumb f*ckers were on for 2, sometimes 4 months. Most everyone on here knows that isn't cool. So if the politicians can get the general public to side that DMAA is bad, very bad, they look like they are doing work on the people's behalf without doing sh*t at all. Plus, it is one more step for Big Pharm, who is sitting in their backpockets, to get a chance to take down an industry that in the end will still have nothing to do with Big Pharma. I won't go to the doctor because I don't have supplements and need something. I don't go now. They see supplement users as customers they are missing out on.

Hey hey. I never said to ban pop. I said people need to be responsible for themselves. All it takes is the govt to get a hook in somewhere and they can pretty much do what they want. You are correct, they probably won't take away protein powder. There are still people in the GENERAL PUBLIC that believe creatine is a steroid. That is who politicians go after when they have an agenda. The general public. It wouldn't do them any good to go against the general LIFTING public because most of us know, even if some are still stupid, that you shouldn't overdo certain supplements, that you should get educated about certain supplements. There was an article in SI about 6 years ago where multiple men were in a jaundiced state due to superdrol and its clones. These dumb f*ckers were on for 2, sometimes 4 months. Most everyone on here knows that isn't cool. So if the politicians can get the general public to side that DMAA is bad, very bad, they look like they are doing work on the people's behalf without doing sh*t at all. Plus, it is one more step for Big Pharm, who is sitting in their backpockets, to get a chance to take down an industry that in the end will still have nothing to do with Big Pharma. I won't go to the doctor because I don't have supplements and need something. I don't go now. They see supplement users as customers they are missing out on.

Anyone ever hear of nasonex? You know the commercial with the friendly bee buzzing around helping people to control allergies. Yea that allergy drug almost killed me..made me gain 60 lbs..gave me sebborheic dermatitis and a plethora of permanent anxiety disorders..oh and it gave me tachardya , cushings syndrome symptoms , stretch marks and high blood pressure. It all went away once I stopped

Anyone ever hear of nasonex? You know the commercial with the friendly bee buzzing around helping people to control allergies. Yea that allergy drug almost killed me..made me gain 60 lbs..gave me sebborheic dermatitis and a plethora of permanent anxiety disorders..oh and it gave me tachardya , cushings syndrome symptoms , stretch marks and high blood pressure. It all went away once I stopped

Exactly friend. That's what I was talking about where drug companies manipulate their findings to get products to the market.